Study of Mirogabalin for Central Neuropathic Pain

Summary

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

Timeline

Start

2019-03-12

Primary completion

2020-12-28

Completion

2020-12-28

Outcome

Met primary endpoint

paper Mirogabalin elicited a statistical and clinically relevant improvement in change from baseline in the weekly ADPS at week 14 PMID 36517235 ↗

registry analysis (superiority test); Mirogabalin vs Placebo; p = 0.0001; Difference of LSM vs placebo -0.71 (95% CI -1.08 to -0.34); ANCOVA NCT03901352 ↗

Publications

• Hosomi K, Katayama Y, Sakoda H, Kikumori K, Kuroha M, Ushida T. Usefulness of Mirogabalin in Central Neuropathic Pain After Stroke: Post Hoc Analysis of a Phase 3 Study by Stroke Type and Location. Pain Ther. 2024 Oct;13(5):1151-1171. doi: 10.1007/s40122-024-00616-3. Epub 2024 Jul 4.
• Ushida T, Katayama Y, Hiasa Y, Nishihara M, Tajima F, Katoh S, Tanaka H, Maeda T, Furusawa K, Kakehi Y, Kikumori K, Kuroha M. Long-Term Safety and Efficacy of Mirogabalin for Central Neuropathic Pain: A Multinational, Phase 3, 52-Week, Open-Label Study in Asia. Pain Ther. 2023 Aug;12(4):963-978. doi: 10.1007/s40122-023-00513-1. Epub 2023 Apr 28.
• Ushida T, Katayama Y, Hiasa Y, Nishihara M, Tajima F, Katoh S, Tanaka H, Maeda T, Furusawa K, Richardson M, Kakehi Y, Kikumori K, Kuroha M. Mirogabalin for Central Neuropathic Pain After Spinal Cord Injury: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Asia. Neurology. 2023 Mar 14;100(11):e1193-e1206. doi: 10.1212/WNL.0000000000201709. Epub 2022 Dec 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirogabalin	Small molecule	10 mg	Oral
Subject	Mirogabalin	Small molecule	15 mg	Oral
Subject	Mirogabalin	Small molecule	20 mg	Oral
Subject	Mirogabalin	Small molecule	30 mg	Oral

Indications